510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901266Substantially Equivalent

Coulter Total Bilirubin Reagent

Coulter Corp., Hialeah FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901266 is the FDA 510(k) clearance record for COULTER TOTAL BILIRUBIN REAGENT, a class II device, cleared for Coulter Corp. on under FDA product code CIG (Diazo Colorimetry, Bilirubin). FDA records list 51 510(k) clearances for Coulter Corp., from to . As of , FDA records show no recalls naming K901266.

Clearance record

Decision date
Received
(40 days to decision)
Product code
CIG Diazo Colorimetry, Bilirubin
Regulation
21 CFR 862.1110
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Coulter Corp. 745 W. 83rd St., Hialeah FL
Third party review
No

Clearances, product code CIG

Trailing 12 months
1 clearance under product code CIG in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CIG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260